HeartScience’s AI ECG Algorithm Secures FDA Breakthrough Status for Aortic Stenosis Detection

FDA Approves HeartSciences' AI ECG Algorithm for Aortic Stenosis with Breakthrough Designation.

HeartSciences has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its AI-based algorithm designed to detect aortic stenosis (AS).

Aortic stenosis is a serious and common heart valve condition that often develops without clear symptoms. If left undiagnosed, it can lead to permanent heart damage and severe health complications. Early signs of the condition are often mild or unnoticed, delaying diagnosis and treatment.

HeartSciences’ new algorithm is designed to identify moderate-to-severe aortic stenosis using AI-powered analysis of ECG data. Once approved, the tool will be available through the company’s MyoVista Insights™ cloud platform, which integrates directly with hospital electronic health record (EHR) systems. No new hardware or tests will be required.

The technology offers several advantages. It may help detect the disease in patients who do not show clear symptoms or are not being fully evaluated. Additionally, it can be applied to ECG data already collected during routine care, either at the time of collection or retrospectively. 

This capability could significantly improve early detection, particularly in areas with limited access to cardiac specialists or advanced imaging services.

The algorithm uses deep learning, specifically convolutional neural networks (CNNs), and was trained on over 120,000 ECG records. Tests have shown it can detect signs of aortic stenosis up to two years before the condition is confirmed by echocardiography. Its accuracy improves as the disease advances.

The FDA Breakthrough Device designation highlights the potential of this innovation to make a meaningful impact on heart disease detection and care.